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(b)(4).Date sent: 1/25/2024.B3: only event year known: 2024.D4: exact product code is unk.D4 is assumed.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.No serial number was provided therefore a device history could not be done.Additional information received: the patient was a four year old that urinated during surgery and had second degree burns.The patient is expected to have plastic surgery.The burns are located on the patient's back.Size of burns, unknown.Photos, not available at time of call.Plastic surgery date, unknown.Account has received the field actions but the account failed to distribute the letter to the or room.The or used the device on the 4 year old patient and the patient urinated during the case and a burn happened.Not sure when the burn was noticed.1st and 2nd degree burn on right buttock cheek.Patient was taken to another hospital for possible skin graft surgery.Hospital pulled all megasoft pads.A thermal warming pad was used with the megasoft pad.0845 possible code.The rep will confirm product code.The rep went over proper cleaning and drying in-service.The rep feels confident that the account is cleaning properly and drying before use.Set up is :table/pad/dressing or sheet/ k-thermal warming pad.We need to know where the warming pad was in relation to the megasoft and patient.The rep described the burn of the photo quarter size shape blister about 8 of them.Outside of blister was red in comparison to other parts of skin.All multiple burns were together.Not sure about the urine was around the burn.The rep is assuming the burn was where the pad was on the patient.The account isn¿t willing to give up the pad for testing at our site.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what is the product code? is the megadyne pad currently being used in the facility.· if no, why not? are there any photos of the burn (s) that you could share with us in regards to the burn? · if yes, please send to (b)(4).Is there any damage(s) noted on the pad? · if yes, where are they and what is the description of the damage(s)? are there photos that can be shared of the pad? · if yes, please send to (b)(4).What is the serial number of the pad? how long has the account been using mega soft?[hs[1] does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? when were the burns first noticed? what is the severity of the burn? (please see degrees of burns below and choose one) · first degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters.· second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful.· third degree burn the burn site looks deep, whitening or blackened and charred.What medical intervention was used to treat the burn (such as salve or stitches)? where is the burn located on the patient? was the reported issue at the pad site or alternate site? besides the burn, did the patient experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? what is the current status of the patient? what was the surgical procedure? what was the surgical procedure date? how long did the surgical procedure last? what cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? was the pad rinsed with water and let dry before this surgical procedure? how was the patient positioned? is it possible the patient was in contact with a metal portion of the or table? how was the room set up to include patient set up and where was the pad in relation to the patient? was there anything between patient and the pad (ex.Sheet, drape, etc.)? were there liquids used in prep? what skin preparation regiment was utilized for the procedure? was urine or other fluids detected in the field after surgery? was there any patient warming blankets used? · if yes, what warming device and/or blankets were used and what is the location in relation to the patient? what temperature setting was used on the warming device(s)? what generator was being used? what power levels was generator set to? was there any diminished effect of the generator noted during the surgery? what monopolar disposables were used during the procedure? what is the age of the patient? if the age of the patient is not known, is the patient an adult or pediatric patient? what ethnicity is the patient? please provide the source or name of person providing answers to follow-up: questions (not the person relaying/submitting answers to loc or chu) these are if they are not already in the complaint already.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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(b)(4).Date sent: 2/27/2024.Additional information was requested, and the following was obtained: what is the product code? 0845.Is the megadyne pad currently being used in the facility? if no, why not? no.Megadyne pads are no longer being used at (b)(6) hospital.All pads have been pulled out of all surgical suites at (b)(6) hospital due to the patient burn on (b)(6) 2024.Are there any photos of the burn (s) that you could share with us in regards to the burn? · if yes, please send to productcomplaint1@its.Jnj.Com.No.Is there any damage(s) noted on the pad? if yes, where are they and what is the description of the damage(s)? no.Nothing visible.· are there photos that can be shared of the pad? · if yes, please send to (b)(6).No.What is the serial number of the pad? (b)(6).How long has the account been using mega soft?[hs[1].The account has used megasoft pads for over 6 years.Does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? unknown.When were the burns first noticed? once the surgery was finished.What is the severity of the burn? (please see degrees of burns below and choose one) the burns were second and third degrees.Patient had to be transferred to the (b)(6) hospital to care for the burns.· first degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters.· second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful.· third degree burn the burn site looks deep, whitening or blackened and charred.What medical intervention was used to treat the burn (such as salve or stitches)? the patient was transferred to the (b)(6) children¿s hospital for care.Skin grafts were used as intervention.Where is the burn located on the patient? patient right buttock.Was the reported issue at the pad site or alternate site? pad site.Besides the burn, did the patient experience any adverse consequence due to the issue? unknown.Are there any anticipated long-term effects from the burn or injury? unknown.What is the current status of the patient? unknown.What was the surgical procedure? bi lateral adenoidectomy.What was the surgical procedure date? (b)(6) 2024.How long did the surgical procedure last? 57 minutes.What cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? quad 42.Was the pad rinsed with water and let dry before this surgical procedure? yes.How was the patient positioned? unknown.Is it possible the patient was in contact with a metal portion of the or table? no.How was the room set up to include patient set up and where was the pad in relation to the patient? unknown.Was there anything between patient and the pad (ex.Sheet, drape, etc.)? there was a sheet between the patient and the megasoft pad.Were there liquids used in prep? unknown.What skin preparation regiment was utilized for the procedure? unknown.Was urine or other fluids detected in the field after surgery? yes.Urine was detected after the surgery.Was there any patient warming blankets used? unknown.· if yes, what warming device and/or blankets were used and what is the location in relation to the patient? what temperature setting was used on the warming device(s)? unknown.What generator was being used? unknown.What power levels was generator set to? unknown.Was there any diminished effect of the generator noted during the surgery? unknown.What monopolar disposables were used during the procedure? valleylab monopolar pencil 6 inch.What is the age of the patient? 4.If the age of the patient is not known, is the patient an adult or pediatric patient? pediatric patient.What ethnicity is the patient? unknown.Additional information received: valleylab ft10.Quicksuite.Norm-o-temp.Gell-roll pediatric size.Sahara super-absorbent operating room table sheet.11 minute surgery.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.
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